Assessment of QoL and Outcomes With SBRT for RCC

Overview

Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely delivers high doses of radiation to tumours. It has been investigated as definitive treatment for an increasing variety of primary tumours including lung, liver, prostate, and now renal cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of RCC.

Full Title of Study: “Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) – AQuOS-RCC”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Detailed Description

There is an evolving body of literature that shows high rates of tumour control and minimal associated toxicities with SBRT to treat RCC. However, the majority of published evidence is retrospective in nature, and there is a scarcity of data on the impact on quality of life and cost-effectiveness of kidney SBRT. The principal aims of this multicentre study are to prospectively assess QoL and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of primary renal cell carcinoma. The study population will include 30 consecutive patients treated with kidney SBRT on a conventional linear accelerator (35-40 Gy in 5 fractions) at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto (OCC) and the Juravinski Cancer Center, Hamilton Health Sciences Centre, McMaster University (JCC).

Interventions

  • Radiation: SBRT
    • 35-40 Gy delivered in 5 fractions

Arms, Groups and Cohorts

  • Experimental: SBRT
    • RCC patients

Clinical Trial Outcome Measures

Primary Measures

  • Patient Quality of Life
    • Time Frame: Up to 5 years after treatment
    • To evaluate quality of life scores

Secondary Measures

  • Cost-Effectiveness
    • Time Frame: Up to 5 years after completion of treatment
    • To assess health utility scores and correlate with QoL
  • Oncologic Outcomes
    • Time Frame: Up to 5 years after completion of treatment
    • To evaluate local control
  • Oncologic Outcomes
    • Time Frame: Up to 5 years after completion of treatment
    • To evaluate progression-free survival
  • Oncologic Outcomes
    • Time Frame: Up to 5 years after completion of treatment
    • To evaluate overall survival
  • Treatment-Related Toxicity
    • Time Frame: Up to 5 years after completion of treatment
    • To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ≥18 years old – Medically inoperable or patient who refuses surgery – Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance – Lesion ≥2.5cm or recurrent lesion following local ablative therapy – Written informed consent – Participants must be able to understand the English-language or with the aid of a translator Exclusion Criteria:

  • ECOG ≥3 – Prior abdominal radiation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Collaborator
    • Juravinski Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: William Chu, MD, MSc, FRCPC, Radiation Oncologist – Sunnybrook Health Sciences Centre

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